MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2CTX #2 PDO 36 X 36

Model Number SXPD2B405

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

It was reported by the sales rep that post-op of a few total knee replacement procedure that the suture broke, and patients dehisced and developed and infection at the wound site.Per surgeon patients were brought back to the operating room where the surgeon cleaned out the wound and re-sutured.No further information was provided to the sales rep.

Manufacturer Narrative

The lot number was not provided therefore a review of the device history records, complaint history and/or retained samples could not be reviewed.No samples were returned for review.No photos of the device or the surgical sites were provided for review.If the lot number, samples or photos become available at a later time, they will be reviewed, tested and the details will be included as part of the investigation file and a follow-up report will be submitted at that time.¿adverse events including wound dehiscence and reactions are common risks/complications of any surgical procedure.There are many causes that can result in the wound opening, sutures failing or reaction, infection, abscess/leakage during or post-operative a procedure: the patient¿s health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition, or chronic medical condition.The surgical procedure ¿ the risk increases with poor surgical techniques such as improper suturing, over-tightened sutures or inappropriate type of suture used for a particular procedure.Other factors - the risk is greater with smoking, obesity, premature post-surgery exercise and heavy lifting.The warning section in the ifu states, ¿this an absorbable material, the use of supplemental non absorbable sutures should be considered by the surgeon in the closure of sites which may undergo expansion, stretching or distention or which may require additional support¿.Without receiving the lot number of the devices utilized for the surgery so device history records and sterility records could be reviewed, culture results to identify the type of infection, receiving sterile samples from the same lot to review/test, receiving photos of the suture/incision post-operative, or receiving detailed information regarding the pre-operative preparation of the device, procedure performed, placement of the suture in the tissue, method of anchoring the device in the tissue, post-operative activities or events that may have occurred or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

• Brand Name: STRATAFIX
• Type of Device: 2CTX #2 PDO 36 X 36
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.; corredor tijuana rosarito 2000; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis jauregui giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 15103454
• MDR Text Key: 296596981
• Report Number: 3010692967-2022-00029
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2022,07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPD2B405
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2022
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention